1. Field of the Invention
This invention relates to a implantable prosthetic device for connection to the fluid flow pathway of a patient, and more particularly to a implantable prosthetic device containing a plurality of tube structures having a filter for trapping objects such as embolic particles.
2. Discussion of Related Art
Increasing numbers and types of intralumenal procedures are being performed on medical patients. For example, there are intravascular blood flow measurement procedures, intravascular atherectomy procedures, intravascular drug therapy procedures, balloon angioplasty procedures, intravascular stent installation procedures, and even intravascular coronary bypass procedures (see, for example, U.S. Pat. No. 5,976,178 to Goldsteen, et al. which is herein incorporated by reference in its entirety). A concern commonly encountered in all these techniques is the accidental release of portions of the clots, plague, thrombus, debris, gas bubbles, or other embolic particulates, resulting in emboli which can lodge elsewhere in the vascular system. The creation and release of embolic particles can also occur spontaneously, absent medical intervention, especially in patients with blood-clotting disorders, such as phlebitis. Such emboli may be extremely dangerous to the patient, and may result in myocardial infarction, stroke, or limb ischemia.
Various devices have been developed to decrease the risk of embolism in patients during such procedures or suffering from such medical conditions. For example, U.S. Pat. No. 5,800,525 to Bachinski, et al. discloses a single bodily fluid filter with an elastic tubular framework that can be installed intralumenally to trap embolic particles in a bodily fluid conduit. However, since this device consists of a single filter, it does not provide for an alternative fluid flow path in the event that the filter becomes clogged.
U.S. Pat. No. 6,168,579 to Tsugita discloses a guidewire insertable within a guiding catheter which allows for the temporary placement of a filter in an artery or vein to capture atherosclerotic plaques and/or thrombi to capture embolic particles generated during endovascular procedures. This device, however, is designed only to capture embolic particles dislodged during the course of medical procedures and cannot be surgically implanted into a fluid flow pathway for long-term protection against naturally occurring emobolic particles.
U.S. Pat. No. 5,370,681 Herweck et al. discloses a polyumenal implantable organ for sustained release of a bioactive material into a fluid flow pathway of a patient. The device comprises a body which defines a multiplicity of capillary lumina and is adapted for connection to the patient's fluid flow pathway to establish fluid flow through the capillary lumina. By seeding selected lumina of the device with a bioactive material, such as a therapeutic agent, diagnostic agent, etc. for contact with the body fluid, such as blood, the fluid can be treated as it passes through the device. This device does not provide a means by which embolic particles are filtered within the fluid flow pathway, and thus, does not serve to decrease a patient's risk of stroke, pulmonary embolism or other potentially deadly medical condition.
U.S. Pat. No. 5,197,976 to Herweck et al. discloses a vascular prosthesis comprising a plurality of parallel tube structures which are attached to one another over at least a portion of their longitudinal axis to form a branched arterial or venous graft for capable of being implanted without the necessity of suturing two grafts together. The tube structures of this device, however, do not comprise filtering devices for capturing hazardous embolic particles within a patient's fluid flow pathway.
Obviously, there are still major disadvantages associated with the existing technology which must be overcome. Specifically, the present day technology fails to provide patients with long-term protection against the potentially fatal conditions that result from blocked fluid flow pathways, including stroke, pulmonary embolism, and ischemia. Until now, there have been no implantable prosthetic devices containing multiple fluid flow pathways and filtering mechanisms to ensure the adequacy of the fluid flow within a patient capable of overcoming this technological shortfall.